QC Supervisor, Microbiology (2nd Shift, 1pm-9:30pm)

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. 

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The QC Microbiology Supervisor will lead, plan, organize, guide, and be responsible for the coordination/performance of the QC Microbiology Laboratory Operations,

This position is located in Lexington, MA and will supervise the 2nd shift which will operate M-F from 1:00-9:30pm. The Supervisor will report to the Manager of Microbiology.

ESSENTIAL JOB FUNCTIONS

• Supervise, train, and mentor the upstream, downstream, drug product, and banking (Cell/Virus) teams.
• Create a high-performance that emphasizes strengths-based execution, accountability, open communication, people development, and continuous improvement.
• Primary contact for troubleshooting and issue resolution or escalation
• Create and follow up on work orders
• Communicate/ coordinate day’s scheduling and staffing plan
• Oversight and execution of all routine and critical operations (upstream, downstream, and cell/virus banking as well as commissioning and validation activities
• Ensure documentation is complete, reviewed, and meets good documentation practices (forms, logbooks, solution records, batch records, etc.)
• Responsible for floor inventory and communicating schedule changes as needed
• Identify and support process changes/improvements or safety/ergonomic improvements.
• Ensure work is carried out in a safe manner, take action on safety issues and risks
• Ensure that the department is in a continuous state of readiness for production and GMP audits.
• When needed, independently perform manufacturing of uniQure’s therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements
• As a system owner of all manufacturing equipment, respond per on-call schedule to CMS alarms, including off-hours and weekends.

SPECIAL WORK REQUIREMENTS

• Ability to troubleshoot equipment and microbiological testing methods.
• Ability to adapt to schedules and priorities changes based on business needs
• Experience creating comprehensive department schedules
• Leadership experience within a high functioning team
• Other duties, as assigned. 

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

Bachelor’s degree in microbiology; other related science will be considered. 

Esse

ON-THE-JOB EXPERIENCE

 

5-15 years of Microbiology laboratory-based experience in a QC testing capacity within a cGMP setting. 

Required

Prior supervisory experience. 

Desired

SKILLS / ABILITIES

 

Excellent microbiological skills and technical experience in GXP environment. 

Essential

Thorough understanding of industry and regulatory testing requirements for QC Microbiology.

Essential

Computer literacy (MS Word, Excel, and LIMS)

Essential

Must possess excellent communication and organizational skills.

Essential

Detail-Oriented

Essential

Self-organ